Direct Healthcare Professional Communication (DHPC) on amfepramone-containing medicines: Withdrawal and revocation of approvals
2023.02.06
Active substance: amfepramone
Amfepramone-containing medicines are no longer available on the EU market, as marketing authorisations have been revoked respectively withdrawn.
Artegodan GmbH and Temmler Pharma GmbH in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform that due to the risk of pulmonary arterial hypertension, cardio- and cerebro-vascular diseases and dependence, in the context of modest short-term benefits of amfepramone treatment the benefit-risk balance of amfepramone-containing medicines is no longer considered favourable. As a consequence, marketing authorisations of these medicines have been revoked respectively withdrawn by the marketing authorisation holders and these medicines are no longer available on the European Union (EU) market.
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN